<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20200105046008N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-05</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Aleo Vera and Olive Oil preventive dressing usage on pressure injury development.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison between the effect of Aleo Vera and Olive Oil preventive dressing usage on pressure injury development in critically ill patients who admitted to intensive care unit (ICU) of Velayat Teaching Hospital, Qazvin.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45483</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Blinding description: In this study, eligible patients will be divided into three groups by non-random sampling method using balls and bag method: 1. Aloe vera group, 2. Olive oil group, and 3. Control group. This process will be performed by a ward nurse who is unaware of the research.</study_design>
      <phase>3</phase>
      <hc_freetext>Pressure injury.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The patients' skin is examined twice a day for 7 days and the sacrum area will be bandaged using an aloe vera gel preventive dressing. Regarding the dressing and the amount and percentage of the mentioned substances, it should be noted that the amount and percentage of the substance used is determined according to the recommendation of the manufacturer and the opinion of the pharmacologist, and the size of the gases is determined according to the opinion of the pharmacologist; Thus, the preventive dressing consists of a simple gas measuring 5 cm2 impregnated with 5 cc of aloe vera, which will be used in the anatomical region of the sacrum to prevent pressure injury. It should be noted that pure aloe vera gel (100%) will be supplied by Siegol company. Intervention 2: Intervention group: The patients' skin is examined twice a day for 7 days and the sacrum area will be bandaged using an olive oil preventive dressing. Regarding the dressing and the amount and percentage of the mentioned substances, it should be noted that the amount and percentage of the substance used is determined according to the recommendation of the manufacturer and the opinion of the pharmacologist, and the size of the gases is determined according to the opinion of the pharmacologist; Thus, the preventive dressing consists of a simple gas measuring 5 cm2 impregnated with 5 cc of olive oil, which will be used in the anatomical region of the sacrum to prevent pressure injury. It should be noted that pure olive oil (100%) will be supplied by Bahar company. Intervention 3: Control group: Patients' skin will be examined twice a day for 7 days, using a preventative dressing without any special substance.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
SPSS file that includes raw data without participants identitty information

When:
after article publishing to one year after this

To whom:
medical science reserchers

Conditions:
scientific

Where to obtain:
correspondence author

How to obtain:
email to correspondence author

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farnoosh Rashvand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qazvin University of Medical Sciences, Shahid Bahonar blvd.</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3419759811</zip>
        <telephone>+98 912 118 3026</telephone>
        <email>n.rashvand@yahoo.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farnoosh Rashvand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qazvin University of Medical Sciences, Shahid Bahonar blvd.</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>-</zip>
        <telephone>+98 912 118 3026</telephone>
        <email>f.rashvand@qums.ac.ir</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The patient or his/her family's informed consent to participate in the study.
Aged above 18 years old.
The absence of pressure injury on arrival at ICU.
Patients with moderate to high risk based on the score they achieved from the Braden criterion at entry (score 14 and below).</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pressure injury development within the first 12 hours after entering the ward.
Conditions where the patient's position cannot be changed, such as patients with spinal cord injury.
Drug sensitivity to Aleo Vera in group 1 and Olive oil in group 2 (according to patient or if sensitivity was observed in the study).
Patient's death</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L89</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pressure ulcer</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The patients' skin is examined twice a day for 7 days and the sacrum area will be bandaged using an aloe vera gel preventive dressing. Regarding the dressing and the amount and percentage of the mentioned substances, it should be noted that the amount and percentage of the substance used is determined according to the recommendation of the manufacturer and the opinion of the pharmacologist, and the size of the gases is determined according to the opinion of the pharmacologist; Thus, the preventive dressing consists of a simple gas measuring 5 cm2 impregnated with 5 cc of aloe vera, which will be used in the anatomical region of the sacrum to prevent pressure injury. It should be noted that pure aloe vera gel (100%) will be supplied by Siegol company</i_keyword>
      <i_keyword>Intervention group: The patients' skin is examined twice a day for 7 days and the sacrum area will be bandaged using an olive oil preventive dressing. Regarding the dressing and the amount and percentage of the mentioned substances, it should be noted that the amount and percentage of the substance used is determined according to the recommendation of the manufacturer and the opinion of the pharmacologist, and the size of the gases is determined according to the opinion of the pharmacologist; Thus, the preventive dressing consists of a simple gas measuring 5 cm2 impregnated with 5 cc of olive oil, which will be used in the anatomical region of the sacrum to prevent pressure injury. It should be noted that pure olive oil (100%) will be supplied by Bahar company</i_keyword>
      <i_keyword>Control group: Patients' skin will be examined twice a day for 7 days, using a preventative dressing without any special substance.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pressure injury. Timepoint: Twice, everyday for 7 day. Method of measurement: Pressure injury staging system.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-09-01</approval_date>
        <contact_name>Ethics Committee of Qazvin University of Medical Sciences</contact_name>
        <contact_address>Qazvin University of Medical Sciences; Shahid Bahonar Boulevard; Qazvin. Qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
